QCRM Production

Validation Pack

The linear panel of samples covers a broad range and provide an ideal way for manufacturer and laboratory to evaluate new IVD products or to troubleshoot existing products.


Traceability to CRM

Each batch of samples are analysed using validated reference methods. All QCRMs are traceable to CRM. Reference values and uncertainty are provided for each sample.


Stability

All samples are filtered to 0.2µm to maintain sterility. The material is stable for at least 12 months at -20oC
Extensive accelerated stability experiments and homogeneity testing have been carried out on all material.


Matrix effects

Extensive commutability experiments have been carried out between the prepared material and patient samples indicating minimal matrix differences

capping


Dispensing

Serum is dispensed aseptically into sterile containers from 1.0 to 5ml vials, securely labelled and stored at -70oC to +4oC. Over 250,000 samples are dispensed annually.


Labelling

Each sample is uniquely labelled to identify date of manufacturer and pool number.


Resources